MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-11 for ALTHIN J5 92128 manufactured by Althin Medical, Inc..
[19702662]
Facilite alleges arterial blood line came loose from adapter during dialysis, resulting in blood spillage of > 100cc. Blood circuit discarded; pt restarted on new dialyzer without incident. Given replacement volume of 200 cc n. G. No furtheer medical intervention required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1994-00294 |
| MDR Report Key | 19249 |
| Date Received | 1994-08-11 |
| Date of Report | 1994-08-09 |
| Date of Event | 1994-07-22 |
| Date Facility Aware | 1994-07-28 |
| Report Date | 1994-08-08 |
| Date Reported to FDA | 1994-08-08 |
| Date Reported to Mfgr | 1994-08-08 |
| Date Added to Maude | 1995-01-31 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALTHIN |
| Generic Name | DIN ADAPTER |
| Product Code | FKB |
| Date Received | 1994-08-11 |
| Catalog Number | J5 92128 |
| ID Number | UNKNOWN |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19166 |
| Manufacturer | ALTHIN MEDICAL, INC. |
| Manufacturer Address | 14600 NW 60TH AVENUE MIAMI LAKES, FL 33014 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-08-11 |